Radiopacity intraluminal medical device

• US 20020143386A1
• Filed: 06/19/2001
• Published: 10/03/2002
• Est. Priority Date: 03/29/2001
• Status: Active Grant

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Davila, Luis A., Wilson, David J., Silver, James, Mendez, Jorge, Trepanier, Christine, Shaw, William D. Jr., Scheidt, Karl K., Pelton, Alan R.
• Granted Patent: US 6,863,685 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: C08L 27/12 containing fluorine atoms

Abstract

A stent or other intraluminal medical device having markers formed from housings integral with the stent and marker inserts having a higher radiopacity than the stent provides for more precise placement and post-procedural visualization in a vessel, by increasing the radiopacity of the stent under X-ray fluoroscopy. The housings are formed integral to the stent and the marker inserts are made from a material close in the galvanic series to the stent material and sized to substantially minimize the effect of galvanic corrosion.

Claims

1. An intraluminal medical device comprising:

a substantially tubular member having open ends, and a first diameter for insertion into a lumen of a vessel and a second diameter for anchoring in the lumen of the vessel; and

at least one marker connected to at least one end of the substantially tubular member, the at least one marker comprising a marker housing and a marker insert having a radius of curvature equal to the radius of curvature of the substantially tubular marker.

2. The intraluminal medical device according to claim 1, wherein the intraluminal medical device comprises a superelastic alloy.

3. The intraluminal medical device according to claim 2, wherein the superelastic alloy comprises from about 50.0 percent to about 60 percent Nickel and the remainder Titanium.

4. The intraluminal medical device according to claim 1, wherein the marker housing comprises the same material as the intraluminal medical device and is integral thereto, thereby forming a unitary structure.

5. The intraluminal medical device according to claim 4, wherein the marker insert comprises a material having a radiopacity higher than that of the material comprising the intraluminal medical device.

6. The intraluminal medical device according to claim 5, wherein the marker insert comprises Tantalum.

7. The intraluminal medical device according to claim 6, wherein the marker insert is secured in the marker housing by frictional, locking engagement.

8. The intraluminal medical device according to claim 7, wherein the marker insert is secured in the marker housing by a protruding ridge.

9. An intraluminal medical device comprising:

a thin-walled, substantially tubular member having open ends, and a first diameter for insertion into a lumen of a vessel and a second diameter for anchoring in the lumen of the vessel, the thin-walled tubular member comprising a superelastic alloy; and

at least one marker connected to at least one end of the thin-walled, substantially tubular member, the at least one marker comprising a marker housing and a marker insert having a radius of curvature equal to the radius of curvature of the substantially tubular marker.

10. The intraluminal medical device according to claim 9, wherein the marker housing comprises the same material as the intraluminal medical device and is integral thereto, thereby forming a unitary structure.

11. The intraluminal medical device according to claim 10, wherein the marker housing defines a substantially elliptical open having a predetermined curvature.

12. The intraluminal medical device according to claim 11, wherein the marker insert comprises a material having a radiopacity higher than that of the material comprising the intraluminal medical device.

13. The intraluminal medical device according to claim 12, wherein the marker insert comprises Tantalum.

14. The intraluminal medical device according to claim 13, wherein the marker insert has a curvature equal to that of the curvature of the opening in the marker housing.

15. The intraluminal medical device according to claim 14, wherein the marker insert has a diameter of 0.02 inches.

16. The intraluminal medical device according to claim 15, wherein the marker insert is secured in the marker housing by frictional, locking engagement.

17. The intraluminal medical device according to claim 16, wherein the marker insert is secured in the marker housing by a protruding ridge.

19. The stent according to claim 18, wherein the marker housing comprises the same material as the stent and is integral thereto, thereby forming a unitary structure.

20. The stent according to claim 19, wherein the marker housing defines a substantially elliptical open having a predetermined curvature.

21. The stent according to claim 20, wherein the marker insert comprises a material having a radiopacity higher than that of the material comprising the stent.

22. The stent according to claim 21, wherein the marker insert comprises Tantalum.

23. The stent according to claim 22, wherein the marker insert has a curvature equal to that of the curvature of the opening in the marker housing.

24. The stent according to claim 23, wherein the marker insert has a diameter of 0.02 inches.

25. The stent according to claim 24, wherein the marker insert is secured in the marker housing by frictional, locking engagement.

26. The intraluminal medical device according to claim 25, wherein the marker insert is secured in the marker housing by a protruding ridge.

27. The stent according to claim 18, further comprising six markers attached to each end of the thin-walled, substantially tubular member.

29. The method of manufacturing an intraluminal medical device according to claim 28, wherein the substantially elliptical opening has an inside and outside diameter.

30. The method of manufacturing an intraluminal medical device according to claim 29, wherein the step of forming a marker insert comprises punching the marker insert from annealed ribbon stock having a high radiopacity, the marker insert having a diameter between the inside and outside diameter of the substantially elliptical opening.

31. The method of manufacturing an intraluminal medical device according to claim 30, wherein the step of seating the marker insert into the substantially elliptical opening comprises:

loading the punched marker insert into the hole of the marker housing; and

coining the punched marker insert with a predefined pressure utilizing a coining tool such that the punched marker insert is forced below the surface of the marker housing and the marker housing deforms to form a protruding ridge.

18. A stent comprising:

a thin-walled, substantially tubular member having open ends, and a first diameter for insertion into a lumen of a vessel and a second diameter for anchoring in the lumen of the vessel, the thin-walled tubular member comprising a superelastic alloy; and

at least one marker connected to at least one end of the thin-walled, substantially tubular member, the at least one marker comprising a marker housing and a marker insert having a radius of curvature equal to the radius of curvature of the substantially tubular marker.

28. A method of manufacturing an intraluminal medical device having improved radiopacity comprising:

forming a substantially tubular lattice from a tubular member having first and second ends, a first diameter for insertion into a lumen of a vessel and a second diameter for anchoring in the lumen of the vessel, the substantially tubular lattice being formed from a superelastic alloy;

forming at least one marker housing from the tubular member that is integral with the substantially tubular lattice, the marker housing defining a substantially elliptical opening and having a predefined radius of curvature;

forming a marker insert having the same radius of curvature as the substantially elliptical opening; and

seating the marker insert into the substantially elliptical opening.